SyntrFuge™-Processed Adipose Tissue for Knee Osteoarthritis
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Syntr Health Technologies, Inc.
Must not be taking: Anticoagulants, NSAIDs, Corticosteroids, others
Disqualifiers: Osteonecrosis, Gout, Inflammatory arthritis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.
Will I have to stop taking my current medications?
You may need to stop taking certain medications like blood thinners, anti-inflammatory drugs, or substances that affect blood clotting for 7 days before and 3 days after the injection. A washout period (time without taking certain medications) of 7 days is allowed. Please consult with the study team for specific guidance on your medications.
What data supports the effectiveness of the treatment SyntrFuge System, Autologous Microsized Adipose Tissue Therapy for knee osteoarthritis?
Research shows that using microfragmented adipose tissue (a type of fat tissue) for knee osteoarthritis can help reduce pain and improve joint function. Studies have found that this treatment can support tissue healing and provide long-lasting relief from symptoms.
12345Is SyntrFuge-Processed Adipose Tissue safe for treating knee osteoarthritis?
Studies show that using processed adipose (fat) tissue for knee osteoarthritis is generally safe, with no adverse effects reported in patients up to one year after treatment.
25678How is the SyntrFuge System treatment different from other treatments for knee osteoarthritis?
The SyntrFuge System treatment is unique because it uses a patient's own adipose (fat) tissue, processed to create a microsized form, which is then injected into the knee to help reduce pain and support tissue regeneration. This approach leverages the regenerative potential of adipose-derived cells, offering a novel alternative to traditional surgical or pharmaceutical treatments.
267910Eligibility Criteria
This trial is for adults aged 35-80 with moderate to severe knee osteoarthritis. Participants must be in good health, not pregnant or nursing, and have a BMI between 20 and 34.9. They should be able to walk and commit to the study schedule. Exclusions include uncontrolled diseases, recent immunosuppressive therapy, coagulation disorders, current drug/alcohol abuse, recent other treatments for osteoarthritis or participation in another study.Inclusion Criteria
I am not pregnant or breastfeeding.
Written Authorization for Use and Release of Health and Research Study Information has been signed
My knee arthritis is moderate to severe.
+8 more
Exclusion Criteria
Subjects planning to become pregnant, are pregnant, or are breast-feeding
I have been diagnosed with osteonecrosis.
Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either adipose tissue processed with the SyntrFuge™ system or standard of care treatment
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Multiple visits over 24 months
Participant Groups
The trial tests the SyntrFuge™ System's effectiveness on knee osteoarthritis by comparing adipose tissue processed with this system followed by an injection of microsized adipose tissue against standard care practices.
2Treatment groups
Experimental Treatment
Group I: SyntrFuge SystemExperimental Treatment1 Intervention
Adipose tissue microsized via the SyntrFuge System
Group II: Standard of CareExperimental Treatment1 Intervention
Steroid Injection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Irvine Site 1Irvine, CA
Irvine Site 2Irvine, CA
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Who Is Running the Clinical Trial?
Syntr Health Technologies, Inc.Lead Sponsor
References
Lipoaspirate processing for the treatment of knee osteoarthritis: a review of clinical evidences. [2021]The autologous lipoaspirate processing allows to obtain a tissue product to be transplanted for regenerative purposes in multiple pathological sites, such as the knee joint affected by osteoarthritic disease. Recently, multiple protocols and devices have been designed for lipoaspirate processing. These protocols and devices do not use enzymatic digestion and respect the principles of the so-called "minimal manipulation in a closed system". In this study, we performed a systematic review of the literature to identify studies in which osteoarthritis was treated by minimally manipulated intra-articular SVF injection and assessment of therapeutic response was reported. All bias scores were analyzed based on the Coleman methodology score modified by Kon et al. [27] and a subsequent linear classification system of articles was proposed. We identified 12 clinical trials in which clinical evaluations were performed inconsistently using different scales of analysis. All studies reported a significant decrease in the patient's symptomatic discomfort, with improvement in joint function and reduction in pain. Most studies do not reach a high-quality level on the linear scale based on the Coleman-Kon scores. Although the treatment of osteoarthritis of the knee with regenerative methods is undoubtedly of interest, being aimed at healing the disease, this study highlights that the trials are numerically limited, and qualitatively not optimal according to the Coleman-Kon score. Reasonably, greater standardization of devices protocols will be desirable in the future. The high clinical potential offered by these methods could be optimized for all patients.
Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months. [2022]Microfragmented adipose tissue (MFAT) has been shown to benefit osteoarthritic patients by reducing pain and supporting tissue regeneration through a mesenchymal stem cell (MSC)-related paracrine mechanism. This observational study of 110 knees assessed patient-centered outcomes of pain, functionality, and quality of life, analyzing their variation at twelve months following one ultrasound-guided intra-articular injection of autologous MFAT for the treatment of knee osteoarthritis (KOA).
Microfragmented Adipose Tissue Versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Prospective Randomized Controlled Trial at 2-Year Follow-up. [2023]Intra-articular microfragmented adipose tissue (MF-AT) injections have been proposed for the treatment of knee osteoarthritis (OA).
Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial. [2023]Current conservative treatments for knee OA provide limited benefits, with symptoms relief for a short amount of time. Regenerative medicine approaches such as the use of microfragmented adipose tissue (mFAT) showed promising results in terms of durable effects and the possibility to enhance tissue healing and counteract the progression of the pathology. Nevertheless, up to today, the large part of clinical data about mFAT use refers to uncontrolled studies, especially in the surgical setting. The purpose of this study was to evaluate the effectiveness of mFAT applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing.
Intra-Articular Injection of Autologous Micro-Fragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: A Prospective Interventional Study. [2023]To investigate the efficacy and safety of autologous micro-fragmented adipose tissue (MF-AT) for improving joint function and cartilage repair in patients with knee osteoarthritis.
Treatment of knee osteoarthritis by intra-articular injection of concentrated autologous adipose tissue: a twenty four month follow-up study. [2021]To evaluate the safety and efficacy of autologous concentrated adipose tissue for the treatment of knee OA.
The Evaluation of Cartilage Regeneration Efficacy of Three-Dimensionally Biofabricated Human-Derived Biomaterials on Knee Osteoarthritis: A Single-Arm, Open Label Study in Egypt. [2023]Full thickness cartilage defects in cases of knee osteoarthritis are challenging in nature and are difficult to treat. The implantation of three-dimensional (3D) biofabricated grafts into the defect site can be a promising biological one-stage solution for such lesions that can avoid different disadvantages of the alternative surgical treatment options. In this study, the short-term clinical outcome of a novel surgical technique that uses a 3D bioprinted micronized adipose tissue (MAT) graft for knee cartilage defects is assessed and the degree of incorporation of such graft types is evaluated via arthroscopic and radiological analyses. Ten patients received 3D bioprinted grafts consisting of MAT with an allogenic hyaline cartilage matrix on a mold of polycaprolactone, with or without adjunct high tibial osteotomy, and they were monitored until 12 months postoperatively. Clinical outcomes were examined with patient-reported scoring instruments that consisted of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and the Knee Injury and Osteoarthritis Outcome Score (KOOS). The graft incorporation was assessed using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score. At 12 months follow-up, cartilage tissue biopsy samples were taken from patients and underwent histopathological examination. In the results, at final follow-up, the WOMAC and KOOS scores were 22.39 ± 7.7 and 79.16 ± 5.49, respectively. All scores were significantly increased at final follow-up (p < 0.0001). MOCART scores were also improved to a mean of 82.85 ± 11.49, 12 months after operation, and we observed a complete incorporation of the grafts with the surrounding cartilage. Together, this study suggests a novel regeneration technique for the treatment of knee osteoarthritis patients, with less rejection response and better efficacy.
Intra-Articular Administration of Autologous Purified Adipose Tissue Associated with Arthroscopy Ameliorates Knee Osteoarthritis Symptoms. [2021]The aim of this study was to evaluate the safety and efficacy of the intra-articular administration of autologous purified adipose tissue to treat knee osteoarthritis (OA) following arthroscopy. Thirty patients with radiological evidence of knee OA were recruited. A small liposuction and arthroscopic lavage and debridement were performed in the same surgical time. The harvested fat was processed intraoperatively with Lipocell (Tiss'You, RSM) to purify the adipose tissue injected into the knee. Clinical evaluations were performed with VAS, Womac, and Lequesne questionnaires before treatment and after 1, 3, 6, and 12 months of follow-up. Pain, measured with VAS, significantly decreased, showing a reduction of 53% after 1 month and 83% after a year. Functional recovery, measured with Womac, showed an improvement of 47% after 1 month post-treatment and 84% after 1 year. No adverse effects have been observed. The intra-articular administration of purified adipose tissue associated with arthroscopic lavage and debridement is a safe and significantly effective strategy in improving the symptoms of knee osteoarthritis in up to 1 year of follow-up.
Non-homologous use of adipose-derived cell and tissue therapies: Osteoarthritis as a case study. [2023]Adipose tissue is widely recognized as an abundant and accessible human tissue that serves as a source of cells and extracellular matrix scaffolds for regenerative surgical applications. Increasingly, orthopedic surgeons are turning to adipose tissue as a resource in their treatment of osteoarthritis and related conditions. In the U.S., the regulatory landscape governing the orthopedic surgical utilization of autologous and allogeneic adipose tissue remains complex. This manuscript reviews the Food and Drug Administration's nomenclature and guidance regarding adipose tissue products. Additionally, it surveys recent pre-clinical and clinical trial literature relating to the application of adipose-derived cells and tissues in the treatment of osteoarthritis.
Adipose Tissue-Derived Stem Cells Retain Their Adipocyte Differentiation Potential in Three-Dimensional Hydrogels and Bioreactors †. [2021]Osteoarthritis (OA) is a common joint disorder with a significant economic and healthcare impact. The knee joint is composed of cartilage and the adjoining bone, a synovial capsule, the infrapatellar fat pad (IPFP), and other connective tissues such as tendons and ligaments. Adipose tissue has recently been highlighted as a major contributor to OA through strong inflammation mediating effects. In this study, methacrylated gelatin (GelMA) constructs seeded with adipose tissue-derived mesenchymal stem cells (ASCs) and cultured in a 3D printed bioreactor were investigated for use in microphysiological systems to model adipose tissue in the knee joint. Four patient-derived ASC populations were seeded at a density of 20 million cells/mL in GelMA. Live/Dead and boron-dipyrromethene/4',6-diamidino-2-phenylindole (BODIPY/DAPI) staining of cells within the constructs demonstrated robust cell viability after 28 days in a growth (control) medium, and robust cell viability and lipid accumulation in adipogenic differentiation medium. qPCR gene expression analysis and protein analysis demonstrated an upregulated expression of key adipogenesis-associated genes. Overall, these data indicate that ASCs retain their adipogenic potential when seeded within GelMA hydrogels and cultured within perfusion bioreactors, and thus can be used in a 3D organ-on-a-chip system to study the role of the IPFP in the pathobiology of the knee OA.